UMIN-CTR Clinical Trial

Basic information
Public title	Efficient oxygen administration method to subjects wearing surgical masks
Acronym	Efficient oxygen administration method to subjects wearing surgical masks
Scientific Title	Efficient oxygen administration method to subjects wearing surgical masks
Scientific Title:Acronym	Efficient oxygen administration method to subjects wearing surgical masks
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate an efficient oxygen administration method in combination with a surgical mask.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	With the concentration stable, the difference in the numerical value of the oxygen concentration in the exhaled breath is the primary endpoint.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	6
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oxygen is administered by three methods: 1. administration from above the surgical mask with a face mask, 2. administration from under the surgical mask with a face mask, and 3. administration from under the surgical mask with a nasal cannula. The order is 1, 2, 3
Interventions/Control_2	The order is 1, 3, 2
Interventions/Control_3	2, 1, 3
Interventions/Control_4	2,3,1
Interventions/Control_5	3,1,2
Interventions/Control_6	3,2,1
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy person
Key exclusion criteria	People with a history of respiratory illness Smoker COVID-19 patient
Target sample size	24

Research contact person
Name of lead principal investigator	1st name shigeru Middle name Last name saito
Organization	Gunma University Hospital
Division name	Anesthesiology
Zip code	371-8511
Address	3-39-15,syowa town maebasi city gunma
TEL	027-220-8698
Email	ymatsuijournal@aoi.com

Public contact
Name of contact person	1st name yusuke Middle name Last name matsui
Organization	Gunma University Hospital
Division name	Anesthesiology
Zip code	371-8511
Address	3-39-15 Showamachi , Maebashi City, Gunma Prefecture
TEL	0272208698
Homepage URL
Email	ymatsuijournal@aoi.com

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	Gunma University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gunma University Hospital
Address	3-39-15 Showamachi , Maebashi City, Gunma Prefecture
Tel	0272208740
Email	ciru_hitotaisho-irb@ml.gunma-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007%2Fs00540-021-02998-6
Number of participants that the trial has enrolled	25
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 05 Month 01 Day
Date of IRB	2021 Year 05 Month 07 Day
Anticipated trial start date	2021 Year 05 Month 20 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 20 Day
Last modified on	2021 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050565